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Optimization of Synthesis Process and Characterization of Sodium Ferric Gluconate Complex

MA Yixuan, WANG Wenting, WU Jiaojiao, PAN Hongchun, LIU Hong*   

  1. Chongqing Engineering Research Center for Pharmaceutical Process and Quality Control,
    College of Pharmaceutical Sciences, Southwest University, Chongqing 400715, China
  • Online:2016-06-25 Published:2016-06-29
  • Contact: PAN Hongchun, LIU Hong

Abstract:

By monitoring the synthetic reaction of sodium ferric gluconate complex, pH value was found to have a significant
impact on the iron content and yield of product. Under controlled pH conditions, specific production rate, iron content and
yield of sodium ferric gluconate complex were investigated. The maximum iron content of 29.9% and the maximum yield
of 129.12% were obtained when the reaction proceeded for 2 h with pH controlled at 11.0. Meanwhile, a 58.77% reduction
in the particle size of sodium ferric gluconate complex as well as a 33.33% decrease in reaction time was found compared to
that without pH control. Comparative analysis revealed that the synthetic reaction of sodium gluconate iron complex was a
process involving complexation, separation and re-aggregation. The results of characterization confirmed the product under
controlled pH condition to be sodium ferric gluconate complex with no change in iron-chelating capacity. Therefore, it has
been found that pH control provides an effective and applicable approach towards the optimization of the preparation process
of sodium ferric gluconate complex for achieving high yield and iron content simultaneously.

Key words: sodium ferric gluconate complex, pH control, reaction process, specific production rate, optimization

CLC Number: